Recall Z-1693-2016 ยท NGY Cannula, Trocar, Ophthalmic
Alcon Research, Ltd.
23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
| Date | May 18, 2016 (initiated Aug 11, 2015) |
| Status | Terminated |
| Reason | The product has potential to leak beyond their design specification. |
| Root cause | Process control |
| Action | The affected consignees were contacted via letter on 8/11/15 to communicate the potential for leakage. |
| Quantity | 225,000 units |
| Distribution | United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.